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Regeneron antibody cocktail used by Trump faces patent suit

Christopher Yasiejko and Susan Decker
Bloomberg

The Regeneron Pharmaceuticals Inc. “antibody cocktail” given to President Donald Trump to treat his Covid-19 symptoms was developed with the unauthorized use of a fluorescent protein, according to a lawsuit by a California company that patented the technology.

Allele Biotechnology and Pharmaceuticals Inc., a closely held company founded in 1999, sued Regeneron on Monday in White Plains, New York, seeking royalties for the use of its mNeonGreen protein in developing the experimental treatment. A separate federal lawsuit was filed in California against Pfizer Inc. and BioNTech SE, partners in the race to develop a Covid-19 vaccine.

In this undated image from video provided by Regeneron Pharmaceuticals on Friday, Oct. 2, 2020, scientists work with a bioreactor at a company facility in New York state, for efforts on an experimental coronavirus antibody drug.

A fluorescent protein is injected into cells so researchers can watch what’s happening – to determine, for example, how a virus reacts to an antibody. The patent for mNeonGreen, issued in March 2019, covers the use of the protein, which Allele said scientific journals have dubbed the “gold standard” for testing the efficacy of antibody and vaccine candidates.

“Only through use of mNeonGreen” were Pfizer and BioNTech able to develop and test their vaccine candidate “at light speed,” Allele said in a complaint filed in federal court in San Diego. That allowed the companies to be first to market with a product that earned them “an immediate $400 million in grants and over $4 billion in sales of the vaccine to date,” Allele said.

“We are still reviewing the details in the complaint, but we disagree that Regeneron has infringed any valid patent and we will vigorously defend our position against this lawsuit,” company spokesman Joe Ricculli said in an email.

Regeneron surged as much as 9.8% in New York trading on news that Trump had received the cocktail, which SVB Leerink analyst Geoffrey Porges called the “ultimate validation” for the drug developer.

Hundreds of organizations and universities, including the U.S. Food and Drug Administration and the National Institutes of Health, have active licenses to use Allele’s technology, Allele said. The San Diego-based company said it reached out to Regeneron several times to negotiate a license, but the requests went unanswered.

Representatives of Pfizer and BioNTech didn’t immediately respond to requests for comment.

Bright Protein

According to Allele’s founder, Chief Executive Officer Jiwu Wang, mNeonGreen is so bright when used in testing that the camera can detect changes in a split second, which enables researchers to look at different antibodies to see which works best in less time. The fluorescent protein was developed without funding from the federal government and most of its licenses are academic and non-transferable, Wang said.

“What we’re really looking for is recognition for Allele’s role in the advancements that are here, and maintaining our patent rights,” Daniel Catron, the company’s executive director of licensing and business development, said in an interview. “And also, just urging others to go ahead and pick up the phone and speak with us.”

Regeneron, Pfizer and BioNTech have “covered a tremendous amount of territory and are moving mountains to put an end to this pandemic,” Catron said. “We’re not looking to slow down that back-end development. We just want to make sure we’re involved in the process.”

Early studies indicate Regeneron’s treatment, which Trump received before leaving the White House for the hospital on Friday, may help reduce virus levels. Patients don’t usually have access to experimental treatments unless they’re part of a clinical trial, but companies consider special requests for so-called compassionate use in limited circumstances.

Allele’s mNeonGreen benefited from what Catron called “an evolutionary accident” – Allele derived it from a protein in fish-like, filter-feeding sea creatures known as lancelets. Its smaller size, exceptional brightness and stability set it apart from other fluorescent proteins.

The cases are Allele v. Regeneron, 7:20-cv-8255, U.S. District Court, Southern District of New York (White Plains); and Allele v. Pfizer, 3:20-cv-1958, U.S. District Court, Southern District of California (San Diego).